US6001861A - Use of pramipexole in the treatment of restless legs syndrome - Google Patents
Use of pramipexole in the treatment of restless legs syndrome Download PDFInfo
- Publication number
- US6001861A US6001861A US09/008,212 US821298A US6001861A US 6001861 A US6001861 A US 6001861A US 821298 A US821298 A US 821298A US 6001861 A US6001861 A US 6001861A
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- United States
- Prior art keywords
- pramipexole
- treatment
- restless legs
- legs syndrome
- day
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- Expired - Lifetime
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/428—Thiazoles condensed with carbocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
Definitions
- the present invention relates to the use of pramipexole or 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzo-thiazole or the (-)-enantiomers thereof, and the pharmacologically acceptable salts thereof, in the treatment of restless leg syndrome.
- Restless leg syndrome is a neurosensorimotor disorder with paresthesias, sleep disturbances and, in most cases, periodic limb movements of sleep (PLMS).
- Pramipexole is a dopamine-D 3 /D 2 agonist the synthesis of which is described in European Patent 186 087 and its counterpart, U.S. Pat. No. 4,886,812. It is known primarily for the treatment of schizophrenia and Parkinson's disease. It is known from German patent application DE 38 43 227 that pramipexole lowers the plasma level of prolactin. Also, this European patent application discloses the use of pramipexole in the treatment of drug dependency. Further, it is known from German patent application DE 39 33 738 that pramipexole can be used to decrease abnormal high levels of thyroid stimulating hormone (TSH).
- TSH thyroid stimulating hormone
- 5,112,842 discloses the transdermal administration of the compounds and transdermal systems containing these active compounds.
- the WO patent application PCT/EP 93/03389 describes pramipexole as an antidepressant agent, while the PCT application PCT/US95/15618 discloses the neuroprotective effects of pramipexole.
- pramipexole and the pharmacologically acceptable salts thereof can be used in the treatment of restless leg syndrome.
- the present invention particularly provides a method for treatment of restless legs syndrome in a patient suffering from or susceptible to such condition comprising the administration of an effective amount of pramipexole.
- pramipexole is meant 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazole, its (-)-enantiomer thereof, and pharmacologically acceptable salts thereof especially (-)-2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazole dihydrochloride (H 2 O).
- 2-Amino-6-n-propyl-amino-4,5,6,7-tetrahydrobenzothiazole, particularly the (-)-enantiomer thereof, and the pharmacologically acceptable acid addition salts thereof can be given for treating RSL.
- the form of conventional galenic preparations consist essentially of an inert pharmaceutical carrier and an effective dose of the active substance; e.g., plain or coated tablets, capsules, lozenges, powders, solutions, suspensions, emulsions, syrups, suppositories, etc.
- Preferred are tablets comprising 0.88 (0.125), 0.18 (0.25), 0.7 (1.0), 088 (1.25) and 1.1 (1.5) mg of Pramipexole base (mg Pramipexole 2HCl), respectively, and further comprising mannitol, maize starch, colloidal silica, polividone and magnesium stearate as excipients.
- the effective dose range is 0.001 to 10.0 mg/day and patient, preferred between 0.001 and 6, more preferred between 0.01 to 6 and especially preferred between 0.75 and 4.5 mg/day and patient p.o.
- pramipexole may also be administered transdermally or by inhalation.
- Dosages should be increased gradually from a starting dose of about 0.264 mg of base per day and then increased every 5-7 days. Providing patients do not experience intolerable side effects, the dosage should be titrated to achieve a maximal therapeutic effect.
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- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Thiazole And Isothizaole Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
Claims (4)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/008,212 US6001861A (en) | 1998-01-16 | 1998-01-16 | Use of pramipexole in the treatment of restless legs syndrome |
US09/427,809 US6194445B1 (en) | 1997-01-17 | 1999-10-27 | Use of pramipexole in the treatment of restless legs syndrome |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/008,212 US6001861A (en) | 1998-01-16 | 1998-01-16 | Use of pramipexole in the treatment of restless legs syndrome |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/427,809 Continuation US6194445B1 (en) | 1997-01-17 | 1999-10-27 | Use of pramipexole in the treatment of restless legs syndrome |
Publications (1)
Publication Number | Publication Date |
---|---|
US6001861A true US6001861A (en) | 1999-12-14 |
Family
ID=21730382
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/008,212 Expired - Lifetime US6001861A (en) | 1997-01-17 | 1998-01-16 | Use of pramipexole in the treatment of restless legs syndrome |
US09/427,809 Expired - Lifetime US6194445B1 (en) | 1997-01-17 | 1999-10-27 | Use of pramipexole in the treatment of restless legs syndrome |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/427,809 Expired - Lifetime US6194445B1 (en) | 1997-01-17 | 1999-10-27 | Use of pramipexole in the treatment of restless legs syndrome |
Country Status (1)
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US (2) | US6001861A (en) |
Cited By (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2001013902A2 (en) * | 1999-08-19 | 2001-03-01 | Boehringer Ingelheim Pharma Kg | Combination of active agents, said combination containing clonidine and pramipexol |
US6410579B2 (en) | 2000-02-23 | 2002-06-25 | Pharmacia & Upjohn Company | Use of pramipexole for the treatment of addictive disorders |
US20020165246A1 (en) * | 2001-03-05 | 2002-11-07 | Andrew Holman | Administration of sleep restorative agents |
US20030036548A1 (en) * | 2001-08-10 | 2003-02-20 | Boehringer Ingelheim Pharma Kg | Method for treating anhedonia using dopamine agonists |
US6602868B2 (en) | 2000-10-31 | 2003-08-05 | Pharmacia & Upjohn Company | Treatments for restless legs syndrome |
US20030176822A1 (en) * | 2002-03-12 | 2003-09-18 | Morgenlander Joel C. | Method of treating restless leg syndrome |
WO2004019949A1 (en) | 2002-08-30 | 2004-03-11 | Kyowa Hakko Kogyo Co. Ltd. | Adenosine a2a receptor antagonists for treating restless legs syndrome or related disorders |
US20040162322A1 (en) * | 1999-09-30 | 2004-08-19 | Jerrold Rosenbaum | Use of pramipexole as a treatment for cocaine craving |
US20050197385A1 (en) * | 2004-02-20 | 2005-09-08 | Schwarz Pharma Ag | Use of rotigotine for treatment or prevention of dopaminergic neuron loss |
US20070072917A1 (en) * | 2003-07-26 | 2007-03-29 | Srz Properties, Inc. | Substituted 2-aminotetralin for the treatment of depression |
US20070093546A1 (en) * | 2003-07-26 | 2007-04-26 | Srz Properties, Inc. | Use of rotigotine for the treatment of depression |
US20070191470A1 (en) * | 2004-03-24 | 2007-08-16 | Dieter Scheller | Use of rotigotine for treating and preventing parkinson's plus syndrome |
US7258871B2 (en) | 2000-10-20 | 2007-08-21 | Neurobiotec Gmbh | Combination of a transdermal therapeutic system and an oral and/or parenteral preparation containing dopamine agonists for the treatment of dopaminergic disease states |
US20080146622A1 (en) * | 2003-12-24 | 2008-06-19 | Srz Properties, Inc. | Use Of Substituted 2-Aminotetralins For Preventive Treatment Of Parkinson's Disease |
US20080262053A1 (en) * | 2005-10-18 | 2008-10-23 | Juergen Reess | Use of Pramipexole for Treating Moderate to Severe Restless Legs Syndrome (Rls) |
US20090247537A1 (en) * | 2008-03-25 | 2009-10-01 | William Dale Overfield | Methods for preventing or treating bruxism using dopaminergic agents |
US20100168119A1 (en) * | 2008-11-05 | 2010-07-01 | Pharmorx, Inc. | Compositions and methods for minimizing or reducing agonist-induced desensitization |
WO2011148243A1 (en) | 2010-05-24 | 2011-12-01 | Lupin Limited | Extended release formulation of pramipexole |
US9278094B2 (en) | 2013-01-30 | 2016-03-08 | Pharmorx Therapeutics, Inc. | Treatments for depression and other diseases with a low dose agent |
US10342977B2 (en) | 2017-01-05 | 2019-07-09 | Noctrix Health, Inc. | Restless leg syndrome or overactive nerve treatment |
US11103691B2 (en) | 2019-10-03 | 2021-08-31 | Noctrix Health, Inc. | Peripheral nerve stimulation for restless legs syndrome |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8690933B2 (en) * | 2009-08-31 | 2014-04-08 | Brigham Young University | System and method for treating symptoms of restless legs syndrome |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0186087B1 (en) * | 1984-12-22 | 1989-08-23 | Dr. Karl Thomae GmbH | Tetrahydro-benzothiazoles, their production and their use as intermediates or drugs |
DE3843227A1 (en) * | 1988-12-22 | 1990-07-05 | Boehringer Ingelheim Kg | Use of 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazole |
DE3933738A1 (en) * | 1989-10-10 | 1991-04-11 | Boehringer Ingelheim Kg | Use of 2-amino:thiazole-derivs. in pharmaceutical products - for the redn. of thyroid-stimulating hormone levels in the blood |
US5112842A (en) * | 1989-11-09 | 1992-05-12 | Boehringer Ingelheim Kg | Transdermal administration of 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazole |
WO1994013287A1 (en) * | 1992-12-05 | 1994-06-23 | Boehringer Ingelheim Kg | Use of 2-amino-6-a-propylamino-4,5,6,7-tetrahydrobenzothiazole (pramipexol) as an anti-depressant drug |
WO1996018395A1 (en) * | 1994-12-15 | 1996-06-20 | Pharmacia & Upjohn Company | Use of pramipexole as a neuroprotective agent |
WO1998031362A1 (en) * | 1997-01-17 | 1998-07-23 | Pharmacia & Upjohn Company | Use of pramipexole in the treatment of restless legs syndrome |
-
1998
- 1998-01-16 US US09/008,212 patent/US6001861A/en not_active Expired - Lifetime
-
1999
- 1999-10-27 US US09/427,809 patent/US6194445B1/en not_active Expired - Lifetime
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0186087B1 (en) * | 1984-12-22 | 1989-08-23 | Dr. Karl Thomae GmbH | Tetrahydro-benzothiazoles, their production and their use as intermediates or drugs |
DE3843227A1 (en) * | 1988-12-22 | 1990-07-05 | Boehringer Ingelheim Kg | Use of 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazole |
DE3933738A1 (en) * | 1989-10-10 | 1991-04-11 | Boehringer Ingelheim Kg | Use of 2-amino:thiazole-derivs. in pharmaceutical products - for the redn. of thyroid-stimulating hormone levels in the blood |
US5112842A (en) * | 1989-11-09 | 1992-05-12 | Boehringer Ingelheim Kg | Transdermal administration of 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazole |
WO1994013287A1 (en) * | 1992-12-05 | 1994-06-23 | Boehringer Ingelheim Kg | Use of 2-amino-6-a-propylamino-4,5,6,7-tetrahydrobenzothiazole (pramipexol) as an anti-depressant drug |
WO1996018395A1 (en) * | 1994-12-15 | 1996-06-20 | Pharmacia & Upjohn Company | Use of pramipexole as a neuroprotective agent |
WO1998031362A1 (en) * | 1997-01-17 | 1998-07-23 | Pharmacia & Upjohn Company | Use of pramipexole in the treatment of restless legs syndrome |
Non-Patent Citations (140)
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